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New TB drug could cut treatment time by two months

NCT ID NCT07209761

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new drug called quabodepistat can shorten treatment for drug-resistant tuberculosis (TB) from 6 months to 4 months. About 532 adults and teens with rifampicin-resistant or multidrug-resistant TB will be randomly assigned to receive either the new shorter regimen or the standard 6-month treatment. The goal is to see if the shorter treatment works just as well and has fewer side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 532 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥14 years 2. Body weight ≥30.0 kg 3. Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent) 4. Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high') 5. Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test 6. Chest radiograph consistent with active TB disease 7. Able to provide sputum sample 8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose 9. Willing to have HIV test (unless previous positive result confirmed) 10. For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load \<200 copies/mL, and CD4 count \>100 cells/mL Exclusion Criteria: 1. Known/suspected resistance to BDQ, PMD, LZD, or QBS 2. Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months 3. Severe extrapulmonary TB 4. Abnormal laboratory values: ALT/AST \>2.5×ULN, Total bilirubin \>1.5×ULN, eGFR \<60 mL/min/1.73m², Hemoglobin \<8 g/dL, Platelets \<100,000 cells/mm³, WBC \<2.0×10⁹/L, ANC \<1000 cells/μL, and HbA1c \>9.0% 5. Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment 6. Co-enrollment in other therapeutic trials 7. QTcF \>450 msec (males) or \>470 msec (females) 8. Clinically significant cardiovascular disorders 9. Bleeding disorders 10. Conditions interfering with X-ray or sputum assessment 11. Drug allergies/hypersensitivity to study medications 12. Pregnancy or breastfeeding 13. Positive drug screen (case-by-case assessment for some substances) 14. Serious mental disorders 15. Karnofsky score \<60 16. BMI \<16.0 kg/m² 17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver) 18. Pulmonary conditions other than TB (silicosis, fibrosis) 19. Active SARS-CoV-2 infection 20. Use of prohibited medications 21. Blood/plasma donation within 30 days 22. Current use of herbal remedies or traditional medicines

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Conditions

The condition(s) this trial relates to.

multidrug-resistant tuberculosis pulmonary tuberculosis rifampicin-resistant tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center - Pulmonology

    NOT_YET_RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Brooklyn Chest Hospital

    NOT_YET_RECRUITING

    Belville, Western Cape, 7405, South Africa

  • Capital Medical University - Beijing Chest Hospital

    RECRUITING

    Beijing, Beijing Municipality, 101100, China

  • Centre for the AIDS Programme of Research in South Africa (CAPRISA)

    RECRUITING

    Durban, KwaZulu-Natal, 4013, South Africa

  • Centro de Investigación del Hospital de Emergencias de Villa el Salvador

    NOT_YET_RECRUITING

    Villa El Salvador, Lima region, 15837, Peru

  • Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital

    RECRUITING

    Johannesburg, Gauteng, 2092, South Africa

  • Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350008, China

  • Hospital Sergio E. Bernales

    NOT_YET_RECRUITING

    Lima, 15313, Peru

  • Huashan Hospital Fudan University

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology

    RECRUITING

    Chisinau, Chisinau City, MD-2025, Moldova

  • Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital

    RECRUITING

    Port Elizabeth, Eastern Cape, 6003, South Africa

  • Japan Anti-Tuberculosis Association Fukujuji Hospital

    NOT_YET_RECRUITING

    Kiyose, Tokyo, 204-8522, Japan

  • Jose B. Lingad Memorial Regional Hospital

    NOT_YET_RECRUITING

    San Fernando City, Central Luzon (Region III), 2000, Philippines

  • Klerksdorp/Tshepong Hospital Complex, Tshepong Hospital, MDR Unit

    RECRUITING

    Klerksdorp, North West, 2574, South Africa

  • Lung Center Of The Philippines

    NOT_YET_RECRUITING

    Quezon City, National Capital Region, 1100, Philippines

  • National Center for Tuberculosis and Lung Disease

    RECRUITING

    Tbilisi, 0101, Georgia

  • Perinatal HIV Research Unit (PHRU) - Chris Hani Baragwanath Academic Hospital

    NOT_YET_RECRUITING

    Soweto, Gauteng, 1835, South Africa

  • Public Health Clinical Center of Chengdu

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • Pusan National University Hospital

    NOT_YET_RECRUITING

    Busan, Pusan-Kwangyokshi, 49241, South Korea

  • Setshaba Research Center

    NOT_YET_RECRUITING

    Pretoria, Gauteng, 0152, South Africa

  • Shandong Public Health Clinical Center

    NOT_YET_RECRUITING

    Jinan, Shandong, 250102, China

  • Shanghai Pulmonary Hospital - Pneumology

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Silang Specialist Medical Center

    RECRUITING

    Silang, Cavite, 4118, Philippines

  • Sizwe Clinical Research Site (CHRU) - Sizwe Tropical Disease Hospital,

    RECRUITING

    Johannesburg, Gauteng, 2131, South Africa

  • Socios en Salud Sucursal Peru

    NOT_YET_RECRUITING

    La Molina, Lima region, 15012, Peru

  • Synergy Biomed Research Institute

    RECRUITING

    East London, Eastern Cape, 5241, South Africa

  • The Aurum Institute - Rustenburg

    NOT_YET_RECRUITING

    Rustenburg, North West, 0299, South Africa

  • The Aurum Institute - Tembisa Hospital Clinical Research Centre

    RECRUITING

    Johannesburg, Gauteng, 1632, South Africa

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    NOT_YET_RECRUITING

    Incheon, Incheon Metropolitan City, 21431, South Korea

  • The Second Hospital of Nanjing

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210003, China

  • The Third People's Hospital of Shenzhen

    NOT_YET_RECRUITING

    Shenzhen, Guangdong, 518112, China

  • Tropical Disease Foundation

    RECRUITING

    Makati City, National Capital Region, 1772, Philippines

  • UCT - Lung Infection and Immunity Unit

    NOT_YET_RECRUITING

    Cape Town, Western Cape, 7700, South Africa

  • UCT Lung Institute

    RECRUITING

    Cape Town, Western Cape, 7700, South Africa

  • Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430032, China

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